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In Search of Harmonization: FDA Finalizes Device CGMP Regulation Harmonization with ISO 13485:2016 | Foley Hoag LLP

On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this...
Foley Hoag Device Single Audit Program Standards Incorporated Drug Administration Development Considerations International Organization Of Standardization

U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule | Hogan Lovells

The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulationโ€™s (QSRโ€™s) current good manufacturing practice (CGMP)...
United States Third Party Service Providers American National Standards Institute International Organization For Standardization Quality System Regulation Amendments International Organization

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ONC Steps into AI Regulation by Imposing Requirements for 'Predictive Decision Support Interventions'; Also Updates Information Blocking Rules | Akin Gump Strauss Hauer & Feld LLP

On December 13, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a wide-ranging final...
Drug Administration Certification Program Updates Health It Modules Revisions To Certification Program Human Services Exchange Framework

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